Ensure the success of your stability program with Element as your experienced CDMO partner, with our wide range of flexible storage conditions, effective program management, robust analytical testing capabilities, and in-depth understanding of the current regulatory landscape.

Stability testing is an integral part of Element’s comprehensive suite of CMC support services, and our expertise extends from method development and validation to clinical stability and release testing. Stability studies are an essential component of regulatory submissions, and are performed throughout the product development life cycle, typically starting at the preclinical stage of drug development, continuing through Phase I-Phase III clinical trials. Stability studies are a fundamental part of post-approval studies, and stability testing of market batches must be conducted regularly after product launch and the implementation of any post-approval changes.

Element offers stability testing in compliance with International Conference on Harmonization (ICH) Q1A-F requirements for IND, ANDA and NDA approvals for FDA regulated human drug products, with extensive experience in the design and execution of stability testing programs per ICH Q5C requirements for biotechnological and biological drugs, in addition to NADA approvals for Veterinary International Conference on Harmonization (VICH). We also offer storage conditions and protocols according to ICH stability requirements based on specific Zone designations. Your national and regional regulatory needs will be met with our phase-appropriate stability study protocols and programs tailored to your specific drug substance and drug product.

Pharmaceutical stability testing

As a strategic CDMO partner, our consultative teams of scientists work alongside clients to develop comprehensive stability programs for drug substances and products that include the characterization of impurities, degradants, and changes in physicochemical characteristics, such as dissolution profiles, disintegration, and friability of solid-dose products, in addition to rheology and viscosities of topical formulations. Our stability chambers, equipped with 24/7 automated monitoring and back-up generators, support a wide range of ambient, intermediate, accelerated, and long-term storage conditions. Commercial stability studies can be supported with cGMP storage conditions relevant to expiration dating of drug products.

Biologics stability testing

Large molecule drug products are particularly sensitive to environmental factors and, compared to small molecule pharmaceuticals, require more complex analytical and bioanalytical methods to evaluate their quality. Due to batch-to-batch variability, specialized storage conditions, and the complexity of biologic drug formulations, stability testing programs may require customization for specific products to ensure they are fit for use. Consequently, a wide range of justified and validated complex analytical methods and instrumentation may be needed to determine stability.

With an increased focus on particulate matter in biopharmaceuticals, along with unpredictable degradation pathways that vary with different proteins, understanding degradation routes is necessary to determine which critical quality attributes (CQAs) are most vulnerable to change throughout the product life cycle. With proven expertise and success in conducting forced degradation, accelerated, short and long-term stability studies for a wide range of biologic modalities, including proteins, biosimilars, antibodies, and more, our teams of knowledgeable scientists can help to establish CQAs.

Leverage our extensive library of existing, robust platform methods that have been developed for a broad range of matrices to quantify product and process impurities and evaluate the quality of biologics.

The Element advantage

Our consultative team has the depth of regulatory and scientific knowledge necessary to help small and large molecule drug developers design a reliable and effective CMC strategy, including the preparation of an effective CMC section of a regulatory submission containing stability data. Enhance the quality and efficiency of your regulatory filing and meet Agency expectations with Element as your CDMO partner throughout the entire drug discovery and development process. With a proven track record of providing comprehensive and complete CMC support for successful regulatory applications, our commitment to applying our scientific expertise is evident.

To learn more about Element’s stability programs for pharmaceuticals and biologics, or to speak with one of our experts, contact us today.

Pharmaceutical stability testing services

  • ICH stability testing services
  • Stability-indicating assay development, including forced degradation studies
  • Real-time & long-term stability
  • Accelerated stability
  • In-use studies
  • Beyond-use stability
  • Photostability testing to ICH guidelines
  • Formulation evaluation stability
  • Follow-up stability testing
  • Freeze-thaw stability studies
  • Stress stability testing
  • R&D stability testing
  • Identification of unknown degradants and impurities
  • Registration batch stability testing
  • In-use stability studies
  • Finished product release
  • Sterility and microbiological assessment
  • Container-closure integrity testing

Stability-indicating analytical methods for large molecule stability programs

  • SDS-PAGE or CE-SDS
  • Western blot
  • Charge heterogeneity (cIEF)
  • Forced degradation studies
  • Stability-indicating chromatography and size-exclusion chromatography (U/HPLC)
  • Spectrophotometry
  • Peptide mapping of proteins and peptides
  • Aggregation analysis by dynamic light scattering (DLS)
  • Total protein quantification by BCA or A280
  • Glycosylation studies
  • Post-translational modifications (PTM)
  • Purity assays
  • Cell-based bioassays and in vitro enzymatic activity assays
  • pH, osmolality, dissolution, and appearance
  • Subvisible particulates and moisture content
  • Active ingredient determination
  • Container-closure integrity
  • Endotoxin, microbial enumeration and sterility testing

Storage conditions for large molecule stability studies

  • Cryogenic freezers
  • 25˚C/60% RH
  • 30˚C/65% RH
  • 40˚C/75% RH
  • 30˚C
  • 2-8˚C
  • -20˚C
  • <-60˚C

Stability program support for regulatory filing pathways

  • 351(a) Biologics license application (BLA) for innovator biologics
  • 351(k) Pathway for biosimilars and interchangeable biologics
  • NDA (New drug application)
  • 505(b)(1) Investigational new drug (IND) application
  • 505 (b)(2) New chemical entity (NCE) pathway
  • 505(j) Abbreviated new drug product (ANDA) for generic drugs
  • OTC (Monograph-based or IND-based)
  • INAD (Investigational new animal drug)
  • NADA (New animal drug application)
  • ANANDA (Abbreviated new animal drug pathway for generic new animal drugs)
  • CNADA (Conditional approval for new animal drugs)

Our team of over 6,000 Engaged Experts in North America, Europe, The Middle East, Australia, Asia and Africa are ready to help you.

Contact The Element Team